MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER

K012478 · I-Stat Corp. · CHL · Aug 20, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012478
• Device Name: MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
• Applicant: I-Stat Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Aug 20, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The i-STAT System is used by trained medical professionals for running clinical chemistry tests for sodium, potassium, chloride, urea nitrogen, glucose, hematocrit, calcium, blood-gases (PCO2, PO2) and blood pH, creatinine, lactic acid, and activated whole blood clotting time in a variety of test panels contained in the i-STAT test cartridges.

Device Story

i-STAT System is a portable clinical analyzer used by trained medical professionals in clinical settings. Device processes whole blood samples via disposable test cartridges to determine clinical chemistry parameters including sodium, potassium, chloride, urea nitrogen, glucose, hematocrit, calcium, blood gases (PCO2, PO2), pH, creatinine, lactic acid, and activated clotting time. System provides rapid diagnostic results to assist healthcare providers in clinical decision-making. This specific submission involves a software modification to reduce interference on the PCO2 test caused by thiopental sodium and propofol.

Clinical Evidence

No clinical data provided. The submission relies on bench testing to validate the software modification regarding PCO2 test interference.

Technological Characteristics

Portable clinical analyzer using disposable cartridges for electrochemical and enzymatic analysis of whole blood. System performs automated measurement of electrolytes, blood gases, metabolites, and clotting time. Software-controlled analysis.

Indications for Use

Indicated for use by trained medical professionals to perform clinical chemistry tests and test panels (including electrolytes, blood gases, pH, metabolites, and clotting time) on whole blood samples.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• Model 100 Portable Clinical Analyzer and Test Pack (K894914, K912387)
• i-STAT Tests for Acid-Base Parameters (K936081)
• i-STAT 200 Portable Clinical Analyzer (K940918)
• i-STAT Creatinine Test (K973292)
• i-STAT Lactate Test (K982071)
• i-STAT Model 200 Portable Clinical Analyzer (K001154)
• i-STAT Model 300 Portable Clinical Analyzer (K001387)
• i-STAT System (K011478)

Submission Summary (Full Text)

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# AUG 2 0 2001

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 C.F.R. § 807.92.

The assigned 510(k) number is K012478

Summary Prepared on: 31 July 2001

# Submitted by:

i-STAT Corporation

104 Windsor Center Drive

East Windsor, NJ 08520

Phone: [phone]

Fax: [phone]

# Contact:

Paul VanDerWerf, Ph.D., Vice President Regulatory Affairs and Quality Assurance

#### Establishment Registration Number: 2245578

#### Identification of the Device

Device Name: i-STAT System (see Table 1 below) Proprietary/Trade Name: i-STAT System Common Name: Portable clinical analyzer Classification Name: See Table 1 Device Classification: ll Regulation Number: See Table 1 Clinical Chemistry (75) Panel: Product Code: See Table 1

| i-STAT Corporation<br>104 Windsor Center Drive<br>East Windsor, NJ 08520 | |
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| Device Name | 510(k)<br>Number | Classification | Regulation | Product<br>Code |
|----------------------------------------------------------|--------------------|-----------------------------------------------------------------------|----------------------|-----------------|
| Model 100 Portable<br>Clinical Analyzer and Test<br>Pack | K894914<br>K912387 | Electrode, ion specific,<br>sodium | 21 C.F.R. § 862.1665 | JGS |
| i-STAT Tests for Acid-Base<br>Parameters; | K936081 | Electrode<br>measurement, blood-<br>gases (pCO2, pO2) and<br>blood pH | 21 C.F.R. § 862.1120 | CHL |
| i-STAT 200 Portable<br>Clinical Analyzer | K940918 | Electrode<br>measurement, blood-<br>gases (pCO2, pO2) and<br>blood pH | 21 C.F.R. § 862.1120 | CHL |
| i-STAT Creatinine Test | K973292 | Electrode, ion based,<br>enzymatic, creatinine | 21 C.F.R. § 862.1225 | CGL |
| i-STAT Lactate Test | K982071 | Acid, lactic, enzymatic<br>method | 21 C.F.R. § 862.1450 | KHP |
| i-STAT Model 200 Portable<br>Clinical Analyzer | K001154 | Electrode, ion specific,<br>sodium | 21 C.F.R. § 862.1665 | JGS |
| i-STAT Model 300 Portable<br>Clinical Analyzer | K001387 | Glucose oxidase,<br>glucose | 21 C.F.R. § 862.1345 | CGA |
| i-STAT System | K011478 | Acid, Lactic, Enzymatic<br>Method | 21 C.F.R. § 862.1450 | KHP |

TABLE 1

# Identification of the Predicate Device.

The predicate device is the i-STAT System (see Table 1 above).

# Description of the Device.

The i-STAT System is used in conjunction with disposable i-STAT cartridges for determination of a variety of parameters in whole blood.

#### Intended Use of the Device.

The i-STAT PCA is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in the i-STAT test cartridges.

#### Reason for Submission.

The software has been modified to diminish the interference on the PCO2 test caused by the drugs thiopental sodium and propofol.

# Conclusion.

These labeling changes do not affect prior substantial equivalence determinations.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines emanating from the eagle's body.

AUG 2 0 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Paul VanDerWerf, Ph.D. Vice President, Regulatory Affairs and Quality Assurance i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520

Re: 510(k) Number: K012478 Trade/Device Name: i-STAT System Regulation Numbers: 862.1120, 862.1145, 862.1170, 862.1225, 862.1345, 862.1600, 862.1665, 862.1770, 864.6400, 864.7140, 862.1450 Regulatory Class: II Product Code: CHL, JGS, CDS, JPI, JBP, JFP, CGZ, CGL, CGA, CEM Regulatory Class: I Product Code: KHP Dated: July 31, 2001 Received: August 2, 2001

Dear Dr. VanDerWerf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE

510(k) Number (if known): K012478

Device Name: i-STAT System

Indications for Use:

The i-STAT System is used by trained medical professionals for running clinical chemistry tests for sodium, potassium, chloride, urea nitrogen, glucose, hematocrit, calcium, blood-gases (PCO2, PO2) and blood pH, creatinine, lactic acid, and activated whole blood clotting time in a variety of test panels contained in the i-STAT test cartridges.

Kusia Alexander for JeanCrops

(Division Sign-Off)
Division of Clinical Laboratory Devices
a) Number K012478

#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| i-STAT Corporation | |
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| 104 Windsor Center Drive | |
| East Windsor, NJ 08520 | |

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